The Food and Drug Administration called its March 25 hearing in the wake of a report by the International Agency for Research on Cancer, part of the World Health Organization. That report, which covered X-rays and other devices that emit radiation, reclassified tanning beds into the highest cancer risk category — “carcinogenic to humans,” along with substances such as tobacco smoke and asbestos. Previously, WHO had classified tanning lamps as “probably” carcinogenic.
The report, published in the journal Lancet Oncology last summer, said that the risk of melanoma increases by 75 percent when use of tanning beds starts before age 30.
In 2005, 8.7 percent of American teens ages 14 to 17 used tanning beds, according to Morbidity and Mortality Weekly Report, which is produced by the Centers for Disease Control and Prevention. Girls were seven times more likely to use them than boys.
Since the mid-1980s, the FDA has regulated tanning beds as Class I medical devices, putting them in the same low-risk category as bandages and tongue depressors. At the hearing, most of the presenters asked the advisory panel to recommend that the FDA either ban the machines outright or at least more strictly regulate their use, especially by minors.
In the end, the panel urged the FDA to make tanning beds Class II or III devices, which would allow the FDA to regulate them more closely. It also recommended that more prominent warning labels be required. (The $5 billion tanning industry is also facing a new 10 percent tax on tanning-bed fees starting July 1, a component of the new health-care legislation. )
Melanoma is the deadliest form of skin cancer, and the CDC estimates that 65 to 90 percent of those tumors are caused by exposure to ultraviolet light or sunlight. Like the sun, tanning beds produce UVA and UVB rays, as well as Vitamin D. Most tanning beds emit about 95 percent UVA rays, which penetrate deep into the skin and give that bronzed look that many people find attractive, and 5 percent UVB rays, which hit the top layers and are most responsible for sunburns. According to the WHO, tanning beds are many times stronger than the midday summer sun in most countries and are therefore more dangerous.
In 2006, the last year for which CDC statistics are available, about 54,000 people in the United States received diagnoses of melanomas of the skin, and 8,441 people died of the disease. The incidence of melanoma has increased by about 3 percent per year since the early 1990s, according to the CDC. The two more common types of skin cancer, basal cell and squamous cell carcinomas, are far more curable but can leave patients with serious physical scars.
Under the Class I regulations, the FDA has required tanning beds to have timers and warning labels, and has obliged salons to provide protective eyewear. The agency recommends that people limit themselves to three or fewer tanning sessions during the first week of use. More than 30 states have supplemental regulations for tanning beds.
However, a study sponsored by the National Cancer Institute and published in the September 2009 issue of the Archives of Dermatology found compliance problems among tanning bed operators. Researchers trained college students to pose as 15-year-old, fair-skinned girls who had never tanned before. The students then called more than 3,600 tanning facilities in all 50 states to inquire about tanning. Although 87 percent of the salons warned the callers that they would need parental consent — many states require parental consent, but it is not an FDA rule — 71 percent said they would allow the callers to tan all seven days the first week. Many of the businesses suggested trying their “unlimited tanning” packages.
John Overstreet, the executive director of the Washington-based Indoor Tanning Association, attended the hearing. He said that parental consent is already standard policy in the industry and that many of the statements presented to the panel didn’t give credit to the FDA for all the regulations that are already in place. At the hearing, tanning industry representatives suggested that taking away tanning beds might push people toward more-dangerous methods of getting darker skin.
“When you tan indoors, you have a regulated environment, in that you know exactly what you’re getting every single time,” Overstreet said. “Also, you have a trained staff person saying, ‘You’re pretty pale, you should only go for five minutes.’ Or, ‘Have you been in the Caribbean? You can go for 10 minutes.’ When you tan outside, it’s very difficult to judge how much exposure you’re getting.”
Overstreet also said that “tremendous flaws” exist in the WHO report and that the federal government shouldn’t base major policy decisions on one report.
Brian O’Donnell, a Maine dermatologist who testified at the hearing, said in a follow-up interview that demanding a “perfect, gold-standard study” on tanning beds is just an attempt to change the subject.
“We can’t do double-blind, placebo-controlled studies, because no institution would ethically allow it to happen, and there’s a reason for that,” he said. “Because everybody knows it causes cancer.”
O’Donnell’s dermatology practice consists 100 percent of skin cancer cases, he said, and he brought a passionate argument against tanning devices to the FDA hearing. He told chilling stories of “the horrors that go on in my office, where I have to take off people’s noses, eyelids and lips.” The most memorable part of his presentation were grisly images of skin cancer surgeries.
As for the purported benefits of tanning beds, O’Donnell acknowledged that they deliver Vitamin D. But he said a customer would need to be in the bed for only a few minutes — not even long enough to get a tan — for the body to produce an adequate amount. Artificial UV radiation can help with skin conditions such as psoriasis, but those treatments are best done in doctor’s offices, not salons, O’Donnell said. (4/20) Washington Post